Health TrialsbyHealthPanel

Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG

ConditionsRefractory EpilepsySleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-65
SponsorXuanwu Hospital, Beijing

About this trial

This study aims to collect electrophysiological and clinical data from patients aged 14-65 with drug-resistant epilepsy who underwent SEEG. The collected data will be analyzed to investigate the functional connectivity during wakefulness and sleep states.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Drug-resistant focal epilepsy

Justified SEEG exploration in the context of presurgical assessment of epilepsy

Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis

Written non-opposition to study participation

Disqualifiers

Pregnant women (Contraindication to SEEG exploration)

Subjects that experience surgical complications during the implant procedure will be excluded from the study

Trial design

Design model

Single group

Treatments tested in this trial

  • SEEG recordings and SPES

    Procedure/Surgery

    This study will utilize stereoelectroencephalography (SEEG) recordings combined with single-pulse electrical stimulation (SPES) to investigate functional brain connectivity and cortical excitability patterns in patients with epilepsy during both wakefulness and sleep states. The SEEG recordings will provide high-resolution intracranial electrophysiological data, while SPES will be employed to actively probe and quantify cortico-cortical connections. This combined approach will enable characterization of state-dependent neural network dynamics.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: SEEG recordings and SPES effectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

SEEG recordings with SPES during daytime and sleeptime

Single-pulse electrical stimulation (SPES) serves as an effective dynamic marker for mapping functional brain connectivity. The stimulation parameters were set at 0.05 Hz, single biphasic pulses, 90 μs per phase, 4 mA.

Time frame
48 hours

Secondary outcomes

1

Dynamic melatonin levels

Collection of melatonin during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement. Salivary melatonin was measured by radioimmunoassay.

Time frame
48 hours
2

Dynamic cortisone levels

Collection of salivary cortisone during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.

Time frame
48 hours
3

Dynamic 11-Deoxycortisol levels

Collection of salivary 11-Deoxycortisol during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.

Time frame
48 hours
4

Dynamic 21-Deoxycortisol levels

Collection of salivary 21-Deoxycortisol during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov
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